Apparatus and methods for developing an anatomic space for laparoscopic hernia repair and patch for use therewith

ABSTRACT

Laparoscopic apparatus and method for insertion into a space or potential space in a body comprising an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/076,771, filed on Feb. 13, 2002, now U.S. Pat. No. 6,758,853; whichis a divisional of U.S. application Ser. No. 09/932,156, filed on Aug.17, 2001, now U.S. Pat. No. 6,565,590, which is a continuation of U.S.application Ser. No. 07/893,988, filed on Jun. 2, 1992, now U.S. Pat.No. 6,312,442, the disclosures of which are hereby incorporated byreference in their entirety.

This invention relates to an apparatus and method for developing ananatomic space for laparoscopic hernia repair and a patch for usetherewith.

In the past, in developing spaces and potential spaces within a body,blunt dissectors or soft-tipped dissectors have been utilized to createa dissected space which is parallel to the plane in which the dissectorsare introduced into the body tissue. This often may be in an undesiredplane, which can lead to bleeding which may obscure the field and makeit difficult to identify the body structures. In utilizing suchapparatus and methods, attempts have been made to develop anatomicspaces in the anterior, posterior or lateral to the peritoneum. The sameis true for plural spaces and other anatomic spaces. Procedures thathave been performed in such spaces include varocele dissection, lymphnode dissection, sympathectomy and hernia repair. In the past, theinguinal hernia repair has principally been accomplished by the use ofan open procedure which involves an incision in the groin to expose thedefect in the inguinal floor, remove the hernial sac and subsequentlysuture the ligaments and fascias together to reinforce the weakness inthe abdominal wall. Recently, laparoscopic hernia repairs have beenattempted by inserting laparoscopic instruments into the abdominalcavity through the peritoneum and then lacing a mesh to cover the herniadefect. Hernia repair sing this procedure has a number of disadvantages,principally because the mesh used for hernia repair is in direct contactwith the structures in the abdominal cavity, as for example theintestines, so that there is a tendency for adhesions to form in betweenthese structures. Such adhesions are known to be responsible for certainoccasionally serious complications. Such a procedure is also undesirablebecause typically the patch is stapled into the peritoneum, which is avery thin unstable layer covering the inner abdomen. Thus, the stapledpatch can tear away from the peritoneum or shift its position. Otherlaparoscopic approaches involve cutting away the peritoneum and staplingit closed. This is time consuming and involves the risk of inadvertentcutting of important anatomic structures. In addition, such a procedureis undesirable because it requires the use of a general anesthesia.There is therefore a need for a new and improved apparatus and methodfor developing an anatomic space and particularly for accomplishinghernia repair by laparoscopy.

In general, it is an object of the present invention to provide anapparatus and method for developing an anatomic space.

Another object of the invention is to provide an apparatus and method inwhich such an anatomic space is developed by applying perpendicularforces to create the anatomic space at the weakest plane to create amore natural, less traumatic and bloodless region in which to work.

Another object of the invention is to provide an apparatus and method toobtain surgical exposure in the preperitoneal space.

Another object of the present invention is to provide an apparatus andmethod of the above character for developing an anatomic space forlaparoscopic hernia repair through the anatomic space.

Another object of the invention is to provide an apparatus and methodfor decreasing the time and risk associated with creating apreperitoneal working space.

Another object of the present invention is to provide an apparatus andmethod of the above character for developing an anatomic space forlaparoscopic hernia repair through the anatomic space.

Another object of the invention is to provide an apparatus and method ofthe above character which requires a minimally invasive procedure.

Another object of the invention is to provide an apparatus and method ofthe above character which can be accomplished without the use of ageneral anesthesia.

Another object of the invention is to provide an apparatus and method ofthe above character which can be accomplished with a spinal or epiduralanesthesia.

Another object of the invention is to provide an apparatus and method ofthe above character which provides substantially reduced medical costsand a greatly reduced patient recovery time.

Another object of the invention is to provide an apparatus of the abovecharacter which is relatively simple and compact.

Another object of the invention is to provide an apparatus and method ofthe above character which can be readily utilized by surgeons.

Another object of the invention is to provide a patch for use in theapparatus which is firmly secured during the hernia repair.

Additional objects and features of the invention will appear from thefollowing description in which the preferred embodiments are set forthin detail in conjunction with the accompanying drawings.

FIG. 1 is a side elevational view partially in cross-section of alaparoscopic apparatus incorporating the present invention.

FIG. 2 is a cross-sectional view taken along the 2—2 of FIG. 1.

FIG. 3 is a side elevational view partially in cross-section of thetunneling shaft forming a part of the apparatus shown in FIG. 1 after ithas been removed from the apparatus shown in FIG. 1.

FIG. 4 is a cross-sectional view taken along the line 4—4 of FIG. 3.

FIG. 5 is an isometric view of the inflatable balloon utilized in theapparatus in FIG. 1 secured to the tunneling rod.

FIG. 6 is a cross-sectional view taken along the line 6—6 of FIG. 5, andshowing by dotted lines the manner in which the balloon as it unfoldsdevelops the anatomic space.

FIG. 7 is a partial plan view of a prone human body, showing the lowerabdomen showing the manner in which the laparoscopic apparatus of thepresent invention is utilized for performing a hernia repair through thepreperitoneal space.

FIG. 8 is a sagittal view of the lower abdominal cavity of the humanbeing shown in FIG. 7 showing the apparatus of the present inventionintroduced into the preperitoneal space.

FIG. 9 is a view similar to FIG. 8 but showing the sleeve removed fromthe apparatus and with the balloon inflated.

FIG. 10 is a sagittal view similar to FIG. 8 showing the balloondeflated and being removed.

FIG. 11 is a sagittal view similar to FIG. 8 showing removal of thetunnelling shaft.

FIG. 12 is an isometric view of a patch incorporating the presentinvention.

FIG. 13 is a side elevational view of the patch shown in FIG. 12.

FIG. 14 is an isometric view showing the patch in FIGS. 12 and 13 in arolled-up, generally cylindrical configuration.

FIG. 15 is a sagittal view showing the hernia sac of hernia that is tobe repaired.

FIG. 16 is a sagittal view showing the introducer through which therolled-up patch in FIG. 17 has been introduced into the preperitonealspace by an introducer rod.

FIG. 17 is a sagittal view similar to FIG. 16 showing the attachment ofthe patch to the hernia sac.

FIG. 18 is a sagittal view similar to FIG. 17 showing the dissection ofthe hernia sac and the unrolling of the patch.

FIG. 19 is a sagittal view showing the patch in place to provide thehernia repair.

FIG. 20 is an isometric view of another embodiment of a balloon with apatch disposed thereon for use with the apparatus of the presentinvention.

FIG. 21 is a cross-sectional view taken along the line 21—21 of FIG. 20.

FIG. 22 is an enlarged cross-sectional view taken along the line 22—22of FIG. 23.

FIG. 23 is a sagittal view showing the manner in which the balloon andpatch shown in FIG. 20 are disposed in the preperitoneal space.

FIG. 24 is a sagittal view showing the placement of the balloon and thepatch of FIG. 20, and the inflation of the balloon in the preperitonealspace.

FIG. 25 is an isometric view of another embodiment of a balloon andpatch for use with the apparatus of the present invention.

FIG. 26 is a rolled-up cross-sectional view of the balloon and patchshown in FIG. 25.

FIG. 27 is an isometric view of another embodiment of a patch for usewith the apparatus of the present invention.

FIG. 28 is an isometric view of the patch shown in FIG. 27 wrapped in anintroducer assembly.

FIG. 29 is a top plan view of another embodiment of laparoscopicapparatus incorporating the present invention.

FIG. 30 is a side elevational view taken along the line 30—30 of FIG.29.

FIG. 31 is a cross-sectional view taken along the line 31—31 of FIG. 30.

FIG. 32 is a cross-sectional view taken along the line 32—32 of FIG. 30.

FIG. 33 is an enlarged cross-sectional view of the distal extremity ofthe laparoscopic apparatus shown in FIG. 29.

FIG. 34 is a partial plan view showing the balloon after it has beenremoved from the laparoscopic apparatus with the obturator tip shiftingits position.

FIG. 35 is a plan view of the balloon shown in FIG. 34 as it is beingremoved from the body of the patient and bringing along with it theobturator tip.

FIG. 36 is a side elevational view of another embodiment of alaparoscopic apparatus incorporating the present invention.

FIG. 37 is a plan view showing the balloon from the apparatus shown inFIG. 36 in an inflated condition and showing the tunneling rod mountedtherein being prevented from being advanced beyond the distal extremityof the balloon.

FIG. 38 is a plan view showing the manner in which the balloon isseparated from the tunneling rod as it is retracted.

In general, the apparatus of the present invention is used for insertioninto a body to create an anatomic space. The apparatus is comprised of atubular introducer member having a bore extending therethrough. Atunneling shaft is slidably mounted in the bore and has proximal anddistal extremities including a bullet-shaped tip. A rounded tunnelingmember is mounted on the distal extremity of the tunneling shaft. Aninflatable balloon is provided. Means is provided on the balloon forremovably securing the balloon to the tunneling shaft. Means is alsoprovided for forming balloon inflation lumen for inflating the balloon.The balloon is wrapped on the tunneling shaft. A sleeve substantiallyencloses the balloon and is carried by the tunneling shaft. The sleeveis provided with a weakened region extending longitudinally thereof,permitting the sleeve to be removed whereby the balloon can be unwrappedand inflated so that it lies generally in a plane. The balloon as it isbeing inflated creates forces generally perpendicular to the plane ofthe balloon to cause pulling apart of the tissue along a natural planeto provide the anatomic space.

More in particular, as shown in the drawings, the apparatus or device 31for creating such an anatomic space for use in a laparoscopic procedure(see FIG. 1) includes an introducer sleeve or device 32 which consistsof a tubular member 33 formed of a suitable material such as plasticwhich is provided with a bore 34 extending throughout the lengththereof. A handle section 36 is mounted on one end of the tubular member33 and is also formed of a suitable material such as plastic. It isprovided with a bore 37 which is in communication with the bore 33. Aflapper valve 38 is mounted within the section 36 and is movable betweena position in which it closes off the bore 37 and position out of theway of the bore 37, by means of a finger operated actuator 39 mounted onthe exterior of the section 36. A stopcock 41 is mounted on the section36 and is in communication with the passage 37. A lever 42 is providedfor opening and closing the stopcock 41.

A tunneling shaft assembly 46 is slidably mounted in the bores 37 and 34of the introducer sleeve 32. The tunneling shaft assembly 46 consists ofa tunneling shaft or rod 47 formed of a suitable material such asstainless steel, of a suitable length, as for example 18 inches, and asuitable diameter of approximately ⅛ inch. The tunneling rod 47 isprovided with proximal and distal extremities 48 and 49.

An introducer member 51 is slidably mounted on the tunneling shaft orrod 47 and is formed of a suitable material such as plastic. Theintroducer member 51 is substantially hollow as shown and is providedwith a bore 52 through which the tunneling shaft 47 extends. Theintroducer member 51 is provided with a substantially hemispherical tip53 to form a rounded protrusion or first obturator through which the rod47 extends. The introducer member 51 has a length such that when it isintroduced into the bore 34 of the introducer sleeve, it extends out ofthe distal extremity of the introducer sleeve 32, as shown particularlyin FIG. 1. This diameter of the introducer member 51 is sized so that itcan be slidably mounted in the bore 34. The other end of the introducermember 51 is provided with a chamfer 54.

A disk-type seal 43 having a central opening is provided in the section36 in alignment with the bore 37, and is adapted to permit theintroduction of the introducer member 51 therethrough.

The section 36 forms one part of a three-piece handle 56 of thelaparoscopic apparatus 31 which is sized so that it is adapted to begrasped by the human hand. As can be seen particularly in FIG. 4, thehandle 56 is generally rectangular in cross-section. The handle 56 isprovided with an intermediate section 57 which has a bore 58 extendingtherethrough in registration with the bore 37 and has the same generaldiameter as the bore 37 so that the introducer member 51 can traveltherethrough. The sections of the handle 56 can be characterized ashaving first, second and third sections, in which section 36 is thefirst section and intermediate section 57 is the second section.Latching means is provided for interconnecting the intermediate section57 to the end section 36, and consists of a pair of oppositely disposedlatches 61 pivotally mounted on the pins 62 in the intermediate section57. Each of the latches 61 is provided with a latch portion 63 adaptedto engage a protrusion 64 provided on the end section 36, and isyieldably urged into engagement therewith by a spring 66. Each of thelatches is provided with a cam surface 67 which is adapted to be engagedby the chamfer 54 of the introducer member 51 to cam the latch portion63 out of engagement with the protrusion 64 to release the intermediatesection 57 from the end section 36 for a purpose hereinafter described.

The handle 56 also consists of another end section 71, which can also becharacterized as the third section, which is secured to the proximalextremity of the tunneling shaft or rod 47. A pair of latches 72 areprovided in the end section 71 and are pivotally mounted on pins 73. Thelatches 72 are provided with latch portions 74 adapted to engageprojections 76 provided in the intermediate section 57. Means isprovided for yieldably retaining the latches 72 in engagement with theprojections 76 and consists of a U-shaped spring 77 mounted within theend section 71 and engaging the latches 72. The latches 72 are providedwith knurled portions 72 a which extend outwardly which are adapted tobe grasped by the fingers of the hand so that the latch portions 74 canbe moved out of engagement with the projections 76 against the force ofthe spring 77.

The tunneling shaft assembly 46 also includes a tunneling member or tip79 which is mounted on the distal extremity of the tunneling shaft orrod 47. As shown, the tip 79 is substantially olive-shaped and can alsobe called a second obturator. It is provided with a roundedhemispherical surface on its distal extremity which has a maximumdiameter which is slightly less than the diameter of the bores 34 and 37so that it can pass through the introducer sleeve 32. The proximalextremity of the tip 79 is of smaller diameter to provide an annularstep 81 in the tip. The proximal extremity of the tip 79 is alsohemispherical, as shown. The tunneling member or tip 79 can be formed ofa suitable material such as plastic and can be secured to the distalextremity of the tunneling shaft or rod 47 by suitable means such as anadhesive. As hereinafter explained, the tunneling shaft or rod 47 ismovable so that the tip 79 can be brought into engagement with thehemispherical end 53 of the introducer member 51 for a purposehereinafter described.

The laparoscopic apparatus 31 also includes a balloon assembly 86 whichis shown in FIGS. 2, 5 and 6. As shown in FIG. 5, when the balloonassembly 86 consists of a balloon 87 which in plan, when deflated, has apear-shaped configuration. The balloon is preferably formed of anon-elastomeric, medical-grade material of a suitable type such as PVC.Thus, the balloon 87 can be formed of two sheets 88 and 89 of such amaterial which have their outer margins bonded together by suitablemeans such as by a heat seal 91 extending around the perimeter of theflat balloon 87. The balloon 87 is provided with a neck 94 into which aflexible tubular member 96 extends, and is secured therein in a suitableairtight fashion such as by an adhesive. The tubular member 96 isprovided with a lumen 97 which is in communication with the interior ofthe balloon and which can be used for inflating the balloon through aLuer-type fitting 98 mounted on the free end of the tubular member 96.

Means is provided for removably securing the balloon 87 to the tunnelingrod or shaft 47, and consists of a sleeve 101 formed of the samematerial as the balloon 87, and which can be formed integral or separatetherefrom and adhered thereto by suitable means such as an adhesive. Thesleeve 101 extends longitudinally of the balloon 87 and is disposedgenerally equidistant from the side margins of the same. The sleeve 101is provided with a passage 102 extending therethrough which is sized toslidably accommodate the tunneling shaft or rod 47. Means is providedfor permitting separation of the balloon 87 from the tunneling rod bymovement sidewise from the axis of the passage 102 and takes the form oflongitudinally spaced apart perforations 103 in the sleeve 101 extendinglongitudinally the length of the sleeve 101. The perforations 103 arespaced close enough together to form a weakened region so that theballoon can be readily separated from the tunneling rod by separatingthe plastic sleeve 101 by tearing the plastic between the perforationsas hereinafter described.

As shown in FIG. 6, the sleeve 101 is disposed equidistant from the sidemargins of the balloon, permitting the balloon to be inflated ashereinafter described and as also shown by the dotted lines in FIG. 6,to be inflated around the rod 47. When deflated, the side margins of theballoon 87 can be rolled inwardly toward the rod 47 as shown by thebroken lines in FIG. 6 to permit the same to be folded into a generallycylindrical configuration as shown in FIG. 2, and to be enclosed withina removable sleeve 106 carried by the tunneling shaft or rod 47. Theremovable sleeve 106 is formed of a relatively thin-walled tubularmember 107 of a suitable material such as Teflon which has a weakenedregion 108 in its wall extending longitudinally the length thereof. Thisweakened region 108 can take the form of a slit as shown, or can be aseries of perforations or slots formed in the wall, or a combinationthereof. The proximal extremity of the tubular member 107 is providedwith split-apart or separable end portions 107 a and 107 b to which aresecured finger rings 109 of a suitable material such as plastic andsecured thereto by fasteners 111.

Operation and use of the laparoscopic apparatus in performing the methodfor laparoscopic hernia repair through preperitoneal space may now bebriefly described as follows. Let it be assumed that the laparoscopicapparatus 31 has been assembled as shown in FIG. 1. As shown in FIG. 7,let it be assumed that a human patient 121 is in a prone position andhas a hernia 122 in the lower abdominal area which he wishes to haverepaired. The patient is prepared in an appropriate manner byadministering a suitable anesthesia, as for example a spinal anesthesia,and any other necessary preparation. The surgeon first makes aninfraumbilical incision 126 in the skin below the navel or umbilicus 127and separates the fat 129 and then incises the anterior rectus sheath orfascia 131 in the midline. Care should be taken not to penetrate theperitoneum overlying the abdominal cavity 133 (see FIG. 8).

After the incision 126 has been made in the manner hereinbeforedescribed, the laparoscopic apparatus 31 is then taken by one hand ofthe surgeon, grasping the handle 56 and utilizing the other hand tofacilitate the insertion of the rounded blunt tip 79 into the incision126. The blunt tip 79 is caused to enter the slit in the fascia 131 andpass anterior to the peritoneum 132, in between the rectus muscles(laterally), and enters the potential preperitoneal space 136 to beprovided for the laparoscopic procedure. The blunt tip 79 is thenutilized as a tunneling device by the surgeon using one hand 56 toadvance the blunt end 79 toward the pubic region of the patient whilethe surgeon places his other hand on the abdomen to feel the apparatusor device 31 as it is being advanced. The advance of the device 31 iscontinued until the blunt tip 79 is below the symphysis pubis 137 asshown in FIG. 8, and preferably is disposed between the symphysis pubis137 and the bladder 138.

After the apparatus or device 31 has been properly positioned as shownin FIG. 8, the removable sleeve or sheath 106 is removed by the surgeonusing one hand to engage the finger rings 109 which are exterior of thebody of the patient and outside of the incision 126. At the same time,the other hand of the surgeon is utilized to stabilize the portion ofthe device 31 which is within the preperitoneal space. The sheath 106can be readily withdrawn since it is formed of Teflon and is split orweakened along its length, by pulling it proximally and away from thelongitudinal axis of the tubular member 33. As the sheath 106 opens andslips off, it exposes the balloon 87 of the balloon assembly 86. Whenthe sheath 106 is completely removed, a sterile saline solution servingas a balloon inflation medium is introduced into the balloon 87 throughthe tubular member 96 by connecting a conventional syringe 141 to theLuer fitting 98. The balloon 87 typically can be inflated to a suitablesize by introducing 500 cc or less of normal saline solution into theballoon by pressing on the plunger 142. As the balloon 87 is inflated,the balloon progressively unwraps with its side margins rollingoutwardly from the center while expanding into a plane to causeprogressive separation or dissection of tissue (i.e. 131, 132) along itsweakest points by application of forces generally perpendicular to theplane of the balloon as indicated by the arrows 143 in FIGS. 6 and 9, tocreate the preperitoneal or anatomic space. The balloon 87 expandsaround the tunneling shaft 47 in the manner shown in broken lines inFIG. 6 to achieve the progressive separation until complete inflation isachieved. The surgeon can sense the filling of the balloon by feelingthe abdomen of the patient as the balloon is inflated. The balloon 87serves to open up the preperitoneal space 136 to provide a bloodlessspace for the procedures hereinafter to be performed. Since the balloonis formed of a non-elastomeric material, it is a volume-limited balloonto prevent overexpansion. Different sizes of balloons can be utilizedfor different patient sizes. With a smaller balloon it is possible todeflate the balloon and then shift the balloon and again reinflate it toobtain the desired bloodless preperitoneal space.

After the desired bloodless anatomic space or pocket 136 is formed, theballoon 87 is deflated by withdrawing the normal saline solution bywithdrawal of the plunger 142 of the syringe 141 or via a hospitalvacuum aspirator. After the balloon 87 has been deflated, the balloonassembly 86 can be removed by grasping the handle 56 of the laparoscopicapparatus or device 31 with one hand and using the other hand to graspthe tubular member 96 and the proximal extremity of the balloon 87 andto remove the same through the incision 126, as shown in FIG. 10. As theballoon 87 is being removed, it is progressively separated from thetunneling rod or shaft 47 by causing the sleeve 101 to split apart alongthe longitudinal perforations 103 provided in the sleeve 101. This makesit possible to separate the balloon 87 from the tunneling rod 47 withoutthe necessity of removing the tunneling rod 47 or the introducer device32.

After the balloon assembly 86 has been removed, the introducer device 32can be advanced distally over the tunneling shaft or rod 47 so itextends well into the preperitoneal space 36 as shown in FIG. 11. Theend section 71 of the handle 56 is then removed by depressing thelatches 72 by having the fingers engage the portions 72 a to disengagethe latch portions 74 from the intermediate section 57 of the handle 56.The end section 71 is then drawn proximally as shown in FIG. 11 to bringthe olive-shaped tip 79 into engagement with the obturator 53 disposedin the distal extremity of the tubular member 33 to cause both the tip79 and the obturator 53 to be withdrawn or retracted. As the introducermember 51 is being withdrawn, its chamfer 54 will strike the camsurfaces 67 of the latches 61 to cause them to disengage from the endpiece 36 to carry it along with the introducer member 51 and shown inFIG. 2. Thus, it can be seen that the tunneling shaft assembly 46 can bereadily removed merely by one motion of the surgeon's hand. Thereafter,a conventional laparoscope 144 (see FIG. 16) can be introduced throughthe introducer sleeve 32 to permit the surgeon to view the preperitonealspace 136.

The dissected preperitoneal space 136 is then insufflated with carbondioxide through the stopcock 41 to a pressure ranging from 6 to 8 mm ofmercury. Thereafter, two additional trocars 146 and 147 are introducedthrough the abdominal wall into the dissected preperitoneal space 136 inappropriate locations. Thus, as shown in FIG. 7, trocar 146 isintroduced into the left side of the abdomen of the patient below theintroducer sleeve 32 and the trocar 147 is introduced into the dissectedpreperitoneal space immediately above the symphysis pubis and directlybelow the introducer sleeve 32. As can be appreciated, the locations ofthe trocars 146 and 147 is generally dictated by the location of thehernia 122 to be repaired.

A patch 151 of the present invention to be utilized in the hernia repairprocedure is shown in detail in FIGS. 12, 13 and 14. The patch 151 canbe characterized as a hernia patch or graft and is made of a suitableplastic mesh such as a Prolene mesh manufactured by Ethicon, Inc. Thepatch 151 can be of any desired configuration. For example it can begenerally circular as shown, and consists of a disk 152 of a suitablediameter, as for example 2 inches. A tail 153 is secured to the disksubstantially in the center thereof, in a suitable manner. For example,as shown, the tail 153 can be provided with split portions 153 a and 153b which are split apart and offset with respect to each other, which aresecured to a smaller reinforcing disk 154 formed of the same material asdisk 152 and secured to the disk 152 by suitable means such as surgicalthread (not shown). The tail 153 is formed of the same material as thedisk 152 and 154, or it can be formed of a different material, such asGoretex. It can have a size such that it has a width of approximately ½inch and a length of approximately 1½ inches. As shown particularly inFIG. 14, the side margins of the disk 152 can be rolled inwardly towardsthe center adjacent the tail 153 to form a cylindrical roll 156 such asshown in FIG. 14 with the tail 153 extending outwardly therefrom. Theroll 156 can be maintained in its rolled-up condition by means ofsutures 157 disposed adjacent opposite ends of the roll and on oppositesides of the tail 153.

Conventional laparoscopic instruments are utilized which are introducedthrough the trocars 146 and 147 while visualizing the same through thelaparoscope 144 introduced through the introducer device 32 to dissectthe hernia 161 to permit visualization of its neck 162 as it is enteringthe internal inguinal ring 163. The hernia sac 161 is dissected from thesurrounding tissue (spermatic duct and vessels) (see FIG. 15). Theprocess is facilitated by CO₂ pressure impinging on the neck of thehernia sac. As soon as this dissection is completed, the roll 156 ispushed into the trocar 147 and advanced through the same by suitablemeans such as a deployment rod 164 (see FIG. 16) to enter the dissectedpreperitoneal space 13 as shown in FIG. 16. Alternatively, the roll 156can be placed in a tubular member (not shown) which can be used toposition the roll 156 within the trocar 157. Thereafter, by thedeployment rod 164, the roll 156 can be pushed out of the tubular memberinto the dissected preperitoneal space 136.

The roll 156 after it is in the preperitoneal space is then manipulatedso that its tail 153 is disposed alongside the neck 162 of the herniasac 161 as shown in FIG. 17. A conventional stapling device 166 is thenintroduced through the trocar 146 to staple the tail 153 to the neck 162by placing staples 167 therein. These staples 167 serve to divide theneck of the sac into distal and proximal portions 162 a and 162 b. Assoon as this stapling operation is completed, the two portions 162 a and162 b are separated from each other because of the pressure of theinsufflation gas to cause the tail 153 of the patch 151 to be pulledupwardly into the inguinal ring to pull with it the disk 152. Thesutures 157 are cut apart to permit the disk 152 to unroll and to beplaced across the inguinal ring 163 which created the main weakness inthe abdominal wall permitting the hernia which is being repaired tooccur. The proximal portion 162 b of the neck 162 is stapled together bystaples 173 as shown in FIG. 18. The proximal portion 162 is thenpermitted to fold back into the desired anatomical location within theabdomen.

Thereafter, while observing the procedure under the laparoscope, thedissected preperitoneal space 136 can be deflated by permitting thecarbon dioxide gas to escape to the atmosphere through the stopcock 41in the introducer device 32 by operation of the stopcock lever arm 42.As deflation is taking place, the movement of the patch 151 is observedthrough the laparoscope 144 so that it does not become misplaced. Whenthe deflation has been completed, the patch 151 is in a position overthe inguinal ring 163 and serves to provide enforcement to prevent theoccurrence of another hernia in that area. The tail 153 is disposed withthe inguinal ring 163 and retains the mesh disk 152 so that it surroundsthe inguinal ring 163.

After deflation has been accomplished, the trocars 146 and 147 as wellas the introducer device 32 can be removed. Small sutures can then beutilized to close the various small openings which have been provided inthe abdominal wall so that upon healing there will be minimal noticeablescars from the procedure. The scar in the navel or umbilicus typicallyis almost nearly invisible.

It has been found that the use of the laparoscopic apparatus 31 inaccomplishing the method as hereinbefore set forth provides a procedurein which the pain after the operation is markedly reduced. This isparticularly true since the operation does not involve suturing of anyligaments which typically produces the pain. In addition, the recoverytime for the patient is greatly accelerated. In the procedure of thepresent invention, a patient can return to work within a matter of 3 to5 days rather than in a number of weeks as in a conventional herniarepair procedure. The procedure also has other advantages. For example,there is a lack of necessity for a general anesthesia. Another principaladvantage of the procedure is there is no contact of mesh patch 151 withthe intestines of the patient or other intra-abdominal structures, thusgreatly reducing the possibility of adhesion formation.

In addition, the graft which is formed by the patch 151 is more secureand is positioned in an anatomically correct position. This is becausethe hernia sac is in exact alignment with the hernia and pulls with itthe tail 153 of the graft to ensure that the graft formed by the patch151 is drawn into the correct position and is maintained in thatposition to prevent migration. In addition, the graft, by having anadditional central disk 154, ensures that additional reinforcement isprovided in the proper location in the center where the weakest regionin the abdominal wall has occurred. In addition, by such propercentering, the mesh construction of the patch 151 serves to uniformlyreinforce the area surrounding the hernia.

Another embodiment of the present invention is shown in FIGS. 20, 21 and22 with respect to another embodiment of a balloon assembly 181 andanother embodiment of a patch or graft 182. The balloon assembly 181consists of a balloon 186 formed of two sheets 187 and 188 which arerectangular in shape, as for example square as shown in FIG. 20, whichare heat-sealed together at their outer margins as indicated by thebroken line 189. A tubular member 191 is provided which has one endsealed into one corner of the balloon 186 as shown in FIG. 20. Thetubular member 191 is provided with a lumen 192 which opens up into theinterior space 193 of the balloon. The sheets 187, 188 are formed of anon-elastomeric material of the type hereinbefore described. A Luerfitting 194 is connected into the free end of the tubular member 191 andis utilized for introducing a saline solution into the balloon 186 forinflating the same.

The graft or patch 182 can have a desired configuration, as for examplecircular as shown in FIG. 20. It is formed of a non-absorbable syntheticsurgical mesh, as for example from polypropylene manufactured by EthiconInc. As shown, the mesh patch 182 overlies the sheet 187.

The balloon assembly 182 with the patch 182 thereon can be rolled upinto a roll 196 as shown in FIG. 22 in which the patch or graft 182 isdisposed within the roll. The roll can be maintained in the rollconfiguration by sutures 197 wrapped about the same. The roll 196 canthen be introduced through a side trocar 146 and introduced into thedissected preperitoneal space 136 with the tubular member 191 extendingthrough the trocar 146 and having its Luer fitting 194 disposed outsideof the trocar. After the roll 196 has been introduced, the sutures 197can be removed and the balloon can be inflated by introducing a salinesolution through the fitting 194 by use of a syringe 199. Before thesaline solution is introduced to inflate the balloon, the roll 196 isproperly positioned so that when it is inflated and begins to unroll itwill unroll in the proper direction so that the graft or patch 182carried thereby is properly positioned as shown in FIG. 23. After theroll 196 has been completely unrolled, continued inflation of theballoon 186 moves the patch 182 so that it is pressed against theportion of the fascia through which the hernia has occurred as shown inFIG. 24. As soon as the graft 182 has been properly positioned, theballoon 186 is deflated. The trocar 146 is then removed, and thereafterthe balloon can be withdrawn through the opening in which the trocar waspresent. Thereafter, the gas utilized for insufflation can be permittedto discharge through another trocar so that the fascia 131 comes intoengagement with the peritoneum 132 with the large-area patch 182 held inplace therebetween. Thereafter, the trocars can be removed in the mannerhereinbefore described to complete the procedure.

Another embodiment of a balloon assembly for deploying a large-areapatch or graft through a trocar is shown in FIG. 25. The large-areagraft 201 shown in FIG. 25 is formed of a mesh material of the typehereinbefore described and has a generally oval-shaped configurationconforming to the general shape of the balloon 202 of the balloonassembly 203. The balloon 202 is constructed of a non-elastomericmaterial in the manner hereinbefore described. A tubular member 206 isprovided for inflating the balloon and has a Luer fitting 207 on thefree end thereof. Means is provided for retaining the mesh graft 201 onone side of the balloon and consists of plastic flaps 208 provided onopposite sides of the balloon 202, and secured thereto by a suitablemeans such as a heat seal along the broken line 209. The inner marginsof the flaps 208 are free and are adapted to receive the outer marginsof the graft 201 as shown particularly in FIG. 25.

The balloon 202 with the mesh graft 201 thereon can be rolled up into asubstantially cylindrical roll 211 by rolling the outer margins of theballoon inwardly on top of the mesh material to provide two rolls 211and 212 which are brought in adjacent to each other as shown in FIG. 26with the mesh graft 201 being wrapped up therewith. The two rolls 211and 212 can then be inserted into a tubular sheath 214. The sheath 214can then be introduced through a trocar in a manner hereinbeforedescribed and then pushed out of the sheath into the abdominal cavity.The balloon can then be inflated with a saline solution to cause the tworolls 211 and 212 to unroll in opposite directions and then for theballoon to inflate to move the patch 201 carried thereby into engagementwith the portion of the fascia having the hernia therein. Thereafter,the balloon can be deflated, the trocar removed, the balloon removed,and the dissected preperitoneal space deflated so that the large meshgraft 201 is disposed between the fascia and the peritoneum and isretained in position therebetween.

Another embodiment of a graft which can be utilized in connection withthe present invention is shown in FIG. 27. The patch or graft 216 isconstructed in a manner similar to the graft or patch 151 shown in FIGS.12 and 13, with the exception that it is constructed in a manner so thatit can be utilized with a direct hernia rather than an indirect inguinalhernia hereinbefore described. The graft 216 is formed of a sheet ofcircular mesh in the form of a disk 217 with a reinforcing central disk218 which has a barbed head 219 secured thereto. The barbed head 219 isformed of a biodegradable material such as polyglycolic acid. The meshgraft 216 can be folded over a deployment rod 221 and introduced into acylindrical sheath 222 (see FIG. 28) which is sized so that it can beintroduced through a conventional trocar, then deployed from the sheath22 by pushing on the deployment rod 221. After the graft 216 has beendeployed into the dissected preperitoneal space 136, it can bepositioned in an appropriate manner so that the barb 219 is positionedso that it is in alignment with the inguinal ring whereby upon deflationof the preperitoneal space 136, the barb 219 will extend through theinguinal ring to serve to retain the graft 201 firmly in place.

Another embodiment of a laparoscopic apparatus incorporating the presentinvention is laparoscopic apparatus 231 as shown in FIGS. 29 through 32.The laparoscopic apparatus 231 includes introducer sleeve or device 32identical to that hereinbefore described. It also includes a tunnelingshaft assembly 46 which is provided with a tunneling shaft or rod 47 anda proximal extremity 49 (see FIG. 32). In the previous embodiment of thelaparoscopic apparatus, the tunneling shaft assembly is provided with anolive-shaped or bullet-shaped tip 79 which was secured to the distalextremity 49 of the tunneling shaft 47. In the present embodiment of theapparatus shown in FIGS. 29 through 32, the obturator tip 79 a isdetachably mounted on the distal extremity 49 of the tunneling rod 47.The proximal extremity of the tip 79 a is provided with a slot 236 whichextends through one side of the proximal extremity into the centralportion of the proximal extremity of the tip 79 a. The slot 236 isadapted to receive the rounded extremity 237 provided on the distalextremity 49 of the tunneling rod 47 (see FIG. 32). A removable sleeve241 is provided as a part of a laparoscopic apparatus 231, and issimilar in many respects to the removable sleeve or sheath 106hereinbefore described. The removable sleeve 241 is formed of a suitablematerial such as Teflon as hereinbefore described and is provided with atubular member 242 which is provided with a relatively thin wall 243that has a weakened portion extending longitudinally thereof in the formof a slit 244 (see FIG. 31). The tubular member 242 is provided with aproximal extremity 246 and a distal extremity 247. The proximalextremity 246 has a thicker cross-section than the distal extremity 247,as shown in FIGS. 31 and 32. The proximal extremity 246 is provided witha recess 248 formed in the wall which is diametrically opposite the slit244 that serves as a relief region to permit the movable sleeve 241 tobe split apart when it is removed from the balloon.

The proximal extremity 246 is provided with wing-like members 251 and252 which extend diametrically therefrom, spaced 90° apart from the slit244. These outstretched wings 251 and 252 serve to help the physicianorient the laparoscopic apparatus 231 as it is being utilized. Theproximal extremity 246 is also provided with a handle 256 which isformed integral therewith and which extends radially from the tubularmember 242. The handle 256 is provided with a finger hole 257 extendingtherethrough through which a finger can be inserted to facilitatepulling the removable sleeve 241 off of the balloon as described inconnection with the previous embodiment.

As shown in FIG. 33, the tip 79 a is detachably mounted in the proximalextremity of the removable sleeve 241 so that the tip 79 can serve as asecond obturator during introduction of the laparoscopic apparatus 231as hereinbefore described. Means is provided for securing the detachabletip 79 a to prevent it from becoming separated from the laparoscopicapparatus 231 and for permitting its withdrawal after the laparoscopicprocedure is being completed. As shown in FIGS. 33 and 34, such meansconsists of a flexible elongate element 261 in the form of a braidedstring formed of a suitable fabric such as Nylon, which has one end 262secured in a slot 263 provided on the distal extremity of the tip 79 aby suitable means such as an adhesive (not shown). The flexible elongateelement 261 extends from the distal extremity of the tip 79 a in arecess 264 opening through the external surfaces of the tip 79 a. Theproximal extremity of the flexible elongate element 261 can be secureddirectly to the balloon 87 or, alternatively, it can extend through theperforated sleeve 101 provided in the balloon along the tunneling shaftso that it extends beyond the proximal extremity of the tunneling shaft.

The use of the laparoscopic apparatus 231 in performing a laparoscopicprocedure is substantially identical to that hereinbefore described withthe exception that when the removable sleeve 241 is removed from theballoon 87, the removable sleeve can be pushed forwardly to detach thetip 79 a from the tunneling shaft 47. The removable sleeve 241 then canbe pulled rearwardly to separate it from the balloon along the slit 244.As soon as this occurs, the tip 79 becomes free of the sleeve and beginsto rotate in the direction of the arrow 266 shown in FIG. 34. When theballoon has been inflated and has performed its functions ashereinbefore described and it is now desired to remove the balloon 87,the balloon 87 can be withdrawn in the manner hereinbefore described,and since the tip 79 a is tethered to the balloon 87 itself or flexibleelongate element 261 attached thereto extends out proximally of theballoon 87, the tip 79 a is withdrawn or can be withdrawn with theballoon 87.

This laparoscopic apparatus 231 with its detachable obturator tip 79 awill be useful in certain applications of the present invention. Withthe previous laparoscopic apparatus hereinbefore described, there is apossibility that when the obturator tip 79 is withdrawn, criticalstructures, as for example small arteries, may be inadvertently incisedbetween the tip 79 and the distal extremity of the tubular member 33 ofthe introducer device 32. This possibility is eliminated by having thedetachable tip 79 a, which is withdrawn when the balloon is withdrawn.

Still another embodiment of the laparoscopic apparatus incorporating thepresent invention is shown in FIGS. 36, 37 and 38, in which thelaparoscopic apparatus 271 consists of a balloon 272 of the typehereinbefore described, which is provided with a perforated sleeve 273through which the tunneling rod 47 extends. The distal extremity 274 ofthe sleeve is closed by an end piece 276. The balloon 272 is wrapped inthe manner hereinbefore described around the tunneling shaft 247. Thetunneling shaft or rod 47 is not provided with a tunneling member orsecond obturator of the type hereinbefore described but its end isrounded as shown by providing a rounded tip 47 a.

The wrapped balloon 272 is enclosed within a removable sleeve 281 whichis similar to those hereinbefore described. It is provided with atubular member 282 that has a weakened region in the form of a slit 283extending longitudinally the length thereof. The removable sleeve 281differs from those hereinbefore described in that rather than being openat the end as in previous embodiments, it is provided with a closed-end,bullet-shaped or olive-shaped tip 286. The slit 283 is provided with acurved portion 283 a which extends through the bullet-shaped tip 286 sothat the sleeve can be peeled off of the balloon 272 in the mannerhereinbefore described by pulling on the handle 288 having a finger hole289 therein. During the time that the removable sleeve 281 is beingpeeled off or separated from the balloon 272, the balloon is held inplace by the tunneling rod 47 which engages the end 276 of theperforated sleeve 273. The balloon 272 after it is inflated can beseparated from the tunneling rod 47 by pulling on the balloon andcausing its distal extremity to lift up and to break apart at theperforations and peel away from the rounded extremities 47 a of thetunneling shaft 47 as shown in FIG. 38. Continued pulling on the balloon272 will cause it to separate from the tunneling rod 47 so that theballoon 272 can be removed as hereinbefore described. Thus, it can beseen that there has been provided an embodiment of the laparoscopicapparatus of the present invention in which the need for an obturatorcarried by the distal extremity of the tunneling rod 47 has beeneliminated by providing the second obturator as a part of the removablesleeve 281. In all other respects, the operation and use of thelaparoscopic apparatus 271 is similar to that hereinbefore described.

From the foregoing it can be seen that there has been provided anapparatus and method for developing an anatomic space by the use of awrapped balloon which, as it is inflated, gradually unwraps to tend toform a plane to cause forces to be created perpendicular to the planefor pulling apart tissue along a natural plane to provide an anatomicspace, thereby providing a dissection in the weakest plane creating amore natural, less traumatic and bloodless region in which to performvarious medical procedures. Such anatomic spaces can be created invarious parts of the human body, for example in the preperitoneal areato provide a space anterior to the peritoneum for hernia repair and forvarocele dissection. Spaces can also be developed lateral to theperitoneum and spaces posterior to the peritoneum for performing medicalprocedures such as a sympathectomy and a lymph node dissection.

As hereinbefore explained, the apparatus and method is particularlyappropriate for performing laparoscopic hernia repair, permitting theuse of grafts and patches which can be used for direct and indirecthernias with minimal pain to the patient and with the patient being ableto return to work within a few days.

1. In an apparatus for creating an anatomic space in tissue in a body,an introducer device having a tubular member with a bore extendingtherethrough, a tunneling shaft assembly slidably mounted in the bore ofthe tublar member, said tunneling shaft assembly including a tunnelingshaft having proximal and distal extremities, a balloon assembly, meanscarried by the balloon assembly for removably securing the balloonassembly to the tunneling shaft, said balloon assembly including aballoon wrapped about said tunneling shaft, a sheath enclosing saidballoon and carried by said tunneling shaft, said sheath having aweakened region extending longitudinally thereof permitting said sheathto be removed to release the balloon, and the balloon having a generallyplanar shape, so that the balloon progressively unwraps, the balloonexpanding to create seperation forces in the tissue generallyperpendicular to the plane of the balloon to create the anatomic space.2. An apparatus as in claim 1 together with a tunneling member mountedon the distal extremity of the tunneling shaft.
 3. An apparatus as inclaim 2 wherein said tunneling member is detachably mounted on saidtunneling shaft.
 4. An apparatus as in claim 3 together with means forsecuring said detachable tunneling member to said balloon so that it canbe removed when said balloon is removed.
 5. An apparatus as in claim 4wherein said means for attaching said detachable tunneling member tosaid balloon includes a flexible elongate element having one end securedto said tunneling member and having the other end extending through theballoon.
 6. An apparatus as in claim 5 wherein said tunneling member isprovided with a bullet-shaped distal extremity and wherein said one endof the flexible elongate element is secured centrally of thebullet-shaped distal extremity and wherein said bullet-shaped distalextremity is provided with a recess formed therein which receives saidflexible elongate element so that the flexible elongate element iswithin the confines of the bullet-shaped distal extremity and extendsfrom the distal extremity towards the balloon.
 7. An apparatus as inclaim 2 wherein said tunneling member is provided with a substantiallyhemispherical surface.
 8. An apparatus as in claim 1 wherein said sheathenclosing said balloon is provided with a distal extremity which issubstantially bullet shaped and wherein said weakened region extendsthrough said distal extremity.
 9. An apparatus as in claim 8 whereinsaid means carried by the balloon assembly for removably securing theballoon assembly to the tunneling shaft includes a sleeve secured tosaid balloon, said sleeve having a weakened region extending along thelength thereof, said sleeve having an end piece disposed at the distalextremity thereof, thereby closing the sleeve to prevent the balloonfrom being separated from the tunneling shaft when the sheath isseparated from the balloon.
 10. An apparatus as in claim 1 together withat least one finger ring secured to said sheath to facilitate removal ofsaid sheath.
 11. An apparatus as in claim 10 together with first andsecond finger members secured to said sheath to facilitate removal ofsaid sheath.
 12. An apparatus as in claim 1 together with a firstobturator slidably mounted on said tunneling shaft and having proximaland distal extremities, the distal extremity thereof having a roundedtip, said tunneling member serving as a second obturator, said first andsecond obturators being of a size so that said first and secondobturators and said tunneling shaft can pass through said bore.
 13. Anapparatus as in claim 1 together with a handle secured to saidintroducer device, said handle being comprised of first, second andthird sections, means securing said first section to said tubularmember, said first section having a bore therein in alignment with thebore in the tubular member, a valve member mounted in said first sectionand movable between first and second position and in the first positionsealing the bore in said first section and in the second positionpermitting free access through the bore, latch means carried by thesecond section for releasably latching said second section to said firstsection and latch means carried by the third section for releasablylatching the third section to the section, means securing the tunnelingshaft to said third section, said third section being detachable fromsaid second section to permit retraction of the tunneling shaft topermit the tunneling member carried by the tunneling shaft to bewithdrawn and brought into engagement with the obturator and to therebyremove the obturator from the tubular member of the introducer device,said obturator including means for operating the latch means of thesecond section to cause the second section to be released from the firstsection to permit the tunneling rod and the obturator to be withdrawn atthe same time from the introducer device solely by retraction of thetunneling rod as it is withdrawn by movement of the third section. 14.An apparatus as in claim 13 whereby said latching means carried by thesecond section includes can surfaces adapted to be engaged by theproximal extremity of the obturator as the obturator is removed byretraction of the tunneling shaft.
 15. An apparatus as in claim 1wherein said sheath is formed of a relatively flexible plastic material.16. An apparatus as in claim 1 wherein said means for removably securingsaid balloon assembly to said tunneling shaft includes a sleeveextending longitudinally of the balloon, said sleeve having a passagetherein, said tunneling shaft being disposed in said passage, saidsleeve having a weakened region extending longitudinally thereofpermitting said balloon assembly to be removed from said tunneling shaftby separation of the sleeve at the weakened section.
 17. An apparatus asin claim 16 wherein said weakened region is formed by a plurality oflongitudinally spaced apart perforations.